A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    130
  • sponsor
    Mayo Clinic
Updated on 23 May 2022
diabetes
cardiovascular disease
hypertension
Accepts healthy volunteers

Summary

The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.

Details
Condition Erectile Dysfunction
Treatment Randomization of two local anesthetics.
Clinical Study IdentifierNCT04801368
SponsorMayo Clinic
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester
≥ 18 years old
Exclusion Citeria
History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
Current or prior history of alcohol or drug abuse (illicit or prescription)
History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
History of cardiac arrhythmia or untreated severe cardiovascular disease
Uncontrolled hypertension
Hepatic insufficiency
Renal insufficiency (CKD stage IIIa or greater)
Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement
Poorly controlled diabetes mellitus (defined as HgbA1c > 8.5 within 30 days of surgery)
Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting)
Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.)
Planned infrapubic or subcoronal incision at the time of penile prosthesis placement
Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia)
Allergy or history of intolerance to any local anesthetic agents included in the protocol
History of prior penile prosthesis or artificial urinary sphincter surgery
Revision penile prosthesis surgery
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